US Stem Cell Inc (USRM)

[Zues]

It does depend on the FDA’s interpretation. Their guidelines are based on interpretations. That is the crux of this dispute. The FDA continues to claim SVF stem cells are sufficiently manipulated to classify it as a drug derived from a biological product, and as such, they have the legal authority to regulate usage.

USRM needs to establish the difference between tissue manipulation via SVF and the creation of a drug. In the case of SVF, they need to prove tissue manipulation does not qualify the product as a drug simply because the process involves separating stem cells from fat where the end product – tissue remnant – is unchanged from its natural state. This is no different than intra-operative autologous blood transfusions which requires manipulation (as I have said earlier) where red blood cells are isolated from other blood products then scrubbed clean before returning to the patient via transfusion. The machine used to carry out the procedure is FDA approved, but the blood (tissue) products are not.

The underlying question here is who should have regulatory authority over stem cell tissue transplant procedures? The FDA claims to have the legal authority. But if the procedures can be reclassified as tissue manipulation without synthesis then it should be no different than any other tissue transplant procedure where FDA regulation/guidance does not apply.